European Medical Device Technology, March 2010, Volume 1, No. 3

The UK’s signature medical cluster continues to be a hotbed of innovation and manufacturing. To continue improving its operations, products and services, however, the med-tech industry must have equitable access to finance.

Parkinson’s disease has a complex aetiology, and is progressive and difficult to treat. It is, however, a prime example of how different medical technologies can be utilised in efforts to provide relief from suffering. This article discusses and compares these different approaches.

A significantly revised European guidance document has been published that will dramatically affect how medical device companies address the European clinical evaluation process and how Notified Bodies will assess compliance with clinical evaluation requirements. Part 1 of this two-part article will discuss important principles underlying the approach taken in the guidance. Part 2 will cover the stages of clinical evaluation and the role of the Notified Body in checking this process.

Implantable polyetheretherketone (PEEK) is a biocompatible and stable polymer that offers a variety of advantages over other accepted implant materials such as ceramics, metals and other polymers. Its properties have been assessed to determine its potential benefits for active implantable medical devices.

A novel electrostatic inchworm micro-actuator with integrated microprobe is described. Using the principle of hydrophobia, the device is made waterproof, which makes it suitable for a range of in vivo applications, including for accurate position control of micro needles in brain applications.

A powerful tool is described that can provide rapid design scenarios, accuracy and realistic images that also contain considerable quantifiable data for device evaluation before manufacture. Application examples include the use of the technique for dental implants and facial reconstruction.

Implementing and conducting a robust and efficient in vitro test validation protocol for transcatheter heart valve devices is complex. This article proposes a method to reduce cost and to optimise the development cycle of these products.

Failures in plastic products are not typically the result of faults in the material or its processing. They are more likely caused by human error and misunderstanding. The many variables that can have a dramatic effect on plastic and product performance are discussed. 

The release of allergenic proteins from the dry natural rubber (DNR) components of prefilled syringes into aqueous pharmaceuticals may potentially induce an immediate allergic reaction in individuals with a latex protein allergy. This article reviews the current risks to patients in the context of vaccine delivery. It also refers to other device applications that contain DNR.

X-ray screening to inspect the quality of products has been instrumental in ensuring the safety and efficacy of medical devices. As devices become more sophisticated and complex, the capabilities of X-ray technology continue to advance.

A more difficult path is likely for medical technology companies entering the United States (US) market. They can expect a number of challenges, including taxes and price controls, and demands for greater rigour and more supporting comparative effectiveness research. The following essay presents the outlook for the industry in the US, where so much is changing.  

Suppliers are finding creative ways to satisfy the sometimes divergent packaging and sterilisation requirements of drug/device products 

A polycarbonate’s internal mould release properties also improve lubricity in the moulded part